Recruiting

GnRH Antagonist

Sponsor:

Oregon Health and Science University

Code:

NCT07111247

Conditions

Cervical Mucus

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Gonadotropin Releasing Hormone Antagonists Relugolix

Study Details

Brief summary:

Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.

Conditions

Cervical Mucus

Study ID

NCT07111247

Start date

Jan 2, 2026

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles
  • BMI >18 and <35
  • Serum p4 >= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle
  • Flexible schedule allowing blood draws on less than 48 hour notice
  • In good general health
  • Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol
  • No objections to taking study drugs
  • No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse

Exclusion Criteria:

  • Oral contraceptive use or other hormone supplement within the preceding 2 months
  • Current cervical infection
  • Evidence of abnormal cervical cytology
  • Use of any IUD for contraception
  • Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera)
  • Contraindications to study drugs
  • Current or past pregnancy within the previous 6 months or currently trying to conceive
  • Desiring to conceive in the next 8 months
  • Breastfeeding in the past 2 months
  • Diagnosed diabetes or metabolic syndrome
  • Diagnosed Polycystic Ovary Syndrome
  • History of, or self-reported, substance abuse
  • Smoker
  • Previous infertility treatment excluding male factor issues
  • Use of an investigational drug within the past 2 months
  • History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone)
  • Current treatment for a vaginal infection such as bacterial vaginosis
  • History of venous thromboembolism (VTE) or inherited thrombophilias

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Relugolix

Participants will take Reugolix for 10 days starting at the midluteal time point (6-9 days after "high fertility" based on ovulation test)

Interventions

Gonadotropin Releasing Hormone Antagonists Relugolix

Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Primary outcome measure

  • Cervical mucus scores [ Time Frame: Cervical mucus will be collected and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation]) ]
  • Single cell transcriptome analysis [ Time Frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation]) ]
  • Proteomic analysis [ Time Frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation]) ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Recruitment Line

503-494-3666whru@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-01-08.